Court bars patent protection for certain gene fragments

The Court of Appeals for the Federal Circuit (CAFC) issued a patent-law decision last month that inevitably will render hundreds of pending patent applications worthless, and that will raise the bar for proving gene and protein related inventions useful.

At issue was whether certain gene fragment sequences were useful. Most notably whether the gene fragments have a specific and substantial use, as required by U.S. patent law.

The CAFC ruled against the patent applicants in In re Fisher. By maintaining the decision of the United States Patent and Trademark Office (USPTO) Board of Patent Appeals and Interferences, the decision bars patent protection for gene fragments that do not have a "specific and substantial" utility. The ramifications of this decision were recognized by some of the largest pharmaceutical and biotechnology companies who submitted amicus curie, or friend of the court, briefs in support of the USPTO.

Patent rights are designed to be quid pro quo. In exchange for sufficient public disclosure of the invention in order to allow others to make and use the invention, the federal government confers a monopoly for a limited time to the inventor. There is a recognized societal benefit received from knowledge shared by inventors.

There are statutory requirements aimed at ensuring that society receives a benefit for this exchange. The patent statutes require a showing of utility, nonobviousness, and novelty prior to granting a limited monopoly for the claimed invention. The USPTO requires that an inventor provide at least one credible disclosure with specific and substantial utility. In the event that a patent is granted absent a specific and substantial utility, the patent may be found invalid. In such a case, the inventor is not providing a value to society, and therefore insufficient quid pro quo.

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The utility requirement has traditionally been the least contentious hurdle to overcome, but for gene fragment patent applications the standard has now been heightened. Regardless of how the decision is interpreted, there is now more predictability as to how the USPTO will determine genetic and protein related inventions. Patent practitioners and inventors are better informed as to what they must provide in order to meet the utility requirement.

What technology was at issue in Fisher?

Two researchers at the Monsanto Company laboratories harvested and purified DNA from the maize plant during its flowering phase, also known as anthesis. Harvesting genetic data during this phase was designed to provide the researchers with valuable information for use in finding what genes were expressed and ultimately what proteins were present at a particular time in the development of the maize plant. Though the researchers were not intending to obtain this information directly through their experiments, they were intending to use the gene fragments they found as a tool in more efficiently obtaining the gene and protein data.

The invention involved DNA sequence fragments that did not specifically encode for a protein and therefore did not entail an entire gene. Nucleotides are the building blocks of DNA, which is nucleic acid. Relatively long sequences of nucleotides make up genes, which when expressed can cause various proteins to be present within a cell. The Fisher patent application was directed to short nucleic acid sequences thought to be gene fragments and specifically referred to as expressed sequence tags (EST). ESTs are thought to be useful as tools for more efficiently identifying previously unknown expressed genes and downstream proteins.

The patent application contained a single claim describing a set of five ESTs that encodes a fragment or entire maize protein. Neither the genes that encode the proteins nor the proteins themselves were claimed because the researchers had not uncovered them at the time of filing the patent application. Essentially, the ESTs were being claimed as a research tool that could be used to obtain the genetic and protein information.

What is specific and substantial utility?

The Fisher decision is one of the first CAFC cases that applied the specific and substantial utility standard to genetic technologies. USPTO Guidelines for applying this standard were finalized in 2001. The guidelines identify that in order to meet this standard, the patent applicant must have a credible assertion "that the claimed invention is useful for any particular practical purpose." The USPTO specifically rules out "throw-away," "insubstantial" and "nonspecific" utilities, including the "use of a complex invention as landfill."

Though the Fisher applicants identified a list of seven uses for the claimed ESTs, the court reasoned that the identified uses were not specific to the claimed ESTs, but could be applied to all ESTs. The CAFC further identified that using ESTs as research tools was too insubstantial to meet the standard. This was in part due to the fact that the applicants did not know what genes, if any, contained the ESTs, nor what proteins may be involved, and why they were important. The CAFC reasoned that though the ESTs could be used for further genomic and proteomic research, this was not enough to fulfill the utility requirement. The CAFC disagreed with Fisher's analogy that the invention was akin to a microscope, which is used for advancing scientific understanding.

How does this affect patents on genetic related technologies?

All pending patent applications that claim ESTs without identifying a use beyond that of a research tool are likely never to be granted. It is unlikely that this decision will be applied to all technologies and more likely that it will be limited to genetic and related technologies. However, it is safe to say that the Fisher decision will be considered carefully when dealing with genomic or proteomic related inventions. Equally as important in this case is the CAFC's underlying lack of desire to grant patent protection for genetic research tools. Considering the advances made in understanding genetics in recent years, this decision is likely to play a significant role in how inventors approach patenting their genetic inventions.

For those disagreeing with the CAFC's decision, it is important to note that Fisher was a 2-1 decision containing a well-reasoned dissenting opinion. In the next couple of months it will become apparent whether the patent applicants intend to appeal the decision directly to the United States Supreme Court.

Jonathan Fritz is an attorney with the law firm of Whyte Hirschboeck Dudek S.C. He is a registered patent attorney with a background in biotechnology, bioinformatics, and computer science. His practice is focused upon intellectual property counseling, information technology and IP litigation. He can be reached at jfritz@whdlaw.com.

The opinions expressed herein or statements made in the above column are solely those of the author, & do not necessarily reflect the views of The Wisconsin Technology Network, LLC. (WTN). WTN, LLC accepts no legal liability or responsibility for any claims made or opinions expressed herein.

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